BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 3022377 · Received March 27, 2013

    Report

    Report Number
    9612164-2013-00336
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    February 27, 2013
    Report Date
    February 27, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: FAILURE TO DELIVER STENT AND STENT DEFORMATION. LESION MORPHOLOGY. DEFORMATION PROBLEM. CONCLUSIONS: LESION MORPHOLOGY. FAILURE TO DELIVER STENT AND STENT DEFORMATION. (B)(4).

    Description of Event or Problem · 1

    THE PHYSICIAN WAS ATTEMPTING TO IMPLANT A RESOLUTE INTEGRITY DRUG ELUTING STENT IN A DIFFICULT HIGHLY CALCIFIED RIGHT. THREE ATTEMPTS WERE MADE TO IMPLANT THE STENT AND DURING THE THIRD ATTEMPT IT WAS NOTICED THAT THE STRUT WAS LIFTED UPRIGHT ON THE STENT. EVALUATION SUMMARY: THE STENT WAS POSITIONED BETWEEN THE MARKER BANDS AS PER SPECIFICATIONS. THE 1ST DISTAL SEGMENT WAS RAISED AND DEFORMED. THE DISTAL TIP WAS DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127206 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006513878

    Patients

    Seq Age Sex Outcome Treatment
    1